Acute Myeloid Leukemia (AML) Clinical Trials

• At the time of signing the informed consent, 18-70 years old (including the critical value);

• Diagnosed with acute myeloid leukemia (except for APL) based on the World Health Organization (WHO) 2022 criteria and meeting the diagnostic criteria for relapsed/refractory AML (refer to the 2023 Chinese Guidelines for the Diagnosis and Treatment of relapsed refractory acute myeloid leukemia);

• Positive expression of CLL1 and/or CD38 in tumor cells;

• Estimated survival ≥3 months;

• Have a confirmed donor for allogeneic hematopoietic stem cell transplantation. After the CAR-T cells were infused, subjects could undergo potential allogeneic hematopoietic stem cell transplantation at any time;

• ECOG score of 0\

• 2 during the screening phase;

• Adequate functional reserve of organs:

∙ Alanine aminotransferase/aspartate aminotransferase ≤2.5× ULN;

‣ Total serum bilirubin ≤2× ULN, except in subjects with congenital bilirubinemia (direct bilirubin ≤1.5× ULN in subjects with Gilbert's syndrome);

‣ Serum creatinine clearance \> 45mL/min (calculated according to Cockcroft-Gault formula);

‣ Left ventricular ejection fraction (LVEF) ≥45%;

‣ Basal finger oxygen saturation ≥92% in room air.

• The ability to discontinue corticosteroids (dexamethasone ≥3mg/ day or other equivalent dose of hormones) from day 7 and continue until 30 days after CAR T cell infusion;

• Pregnant women of childbearing potential should be negative for HCG (immunofluorescence) tests during screening and baseline. Male subjects must agree not to donate sperm for at least two years after the infusion. Male subjects and his sexual partner with childbearing potential must agree to use highly effective contraception for at least 2 years after the infusion;

⁃ Agree to follow-up in accordance with the protocol and the requirements outlined in the informed consent form;

⁃ Voluntarily sign the ICF.